Research Policies and Templates for Sponsors

In the table below, you will find a list of resources for research hosts. These include Standard Operating Procedure documents (SOPs) and template forms. You can use the links in the table to access the relevant materials.

R&I Reference	Trust Reference	SOP Title and Link	Associated Resources
C-2001	C39/2015	Informed Consent Procedure in Hosted Research in UHL Research & Innovation	Appendix 1 – Blank DoA & Signature Log
C-2002	BC18/2013	UHL Safety Reporting for Hosted Studies	Appendix 1 – Pregnancy Notification Form Appendix 2 – SAE Line Listing for UHL-Hosted CTIMP Studies Appendix 3 – SAE Line Listing for UHL-Hosted Non-CTIMP Studies Appendix 4 – Template Email Text to Request Annual SAE Line Listing for UHL-Hosted Studies Appendix 5 – Template Email for Second Reminder Annual SAE Line Listing for UHL-Hosted Studies Appendix 6 – Template Email Text for Final Reminder Annual SAE Line Listing for UHL-Hosted Studies Appendix 7 – Email Request for Further Information/Clarification with Regards to Submitted SAE Line Listing Appendix 8 – Acknowledgement Email SAE Line Listing for Hosted Studies Appendix 9 – UHL SAE Line Listings for Hosted Studies Review Process Flowchart
C-2003	C52/2015	PI Responsibilities for Hosted Research in UHL	Appendix 1 – Roles and Responsibilities of Principal Investigator Agreement Appendix 2 – Blank DoA & Signature Log
C-2006	B21/2023	Expressions of Interest (EOI), Feasibility and Site Selection for Hosted Research at UHL
C-2009	C14/2016	Management of Essential Documents & Study Filing for Hosted Research in UHL	Appendix 1 – Investigator Site File Index for Clinical Trials of Investigational Medicinal Products Appendix 1a – Investigator Site File Index for Non-UKCA/CE Marked Medical Device Studies Appendix 2 – Investigator Site File Index for Studies Not Involving Investigational Medicinal Products Appendix 2a – Investigator Site File Index for Studies of UKCA/CE Marked and Proof of Concept Studies Appendix 3 – Version Control Document
C-2011	C271/2016	Authorisation of Amendments & Additional Documents for Hosted Research in UHL
C-2013	C273/2016	Procedure in Event of Non-Compliance for Hosted Research in UHL
C-2014	C274/2016	Management & Production of CAPA for Hosted Research in UHL	Appendix 1 – Corrective Action Preventative Action (CAPA) Form
C-2015	C275/2016	Identifying & Reporting Deviations/Serious GCP Breaches/Protocol for Hosted Research in UHL	Appendix 1 – Site File Note
C-2018	C278/2016	End of Study Reporting Requirements for Hosted Research in UHL Research & Innovation
C-2025	B52/2020	UHL Pandemic Priority Expedited C&C Assessment Process
C-2028	B1/2021	UHL Remote Monitoring for Research Studies Hosted by UHL	Appendix 1 – Remote Monitoring Risk Assessment
C-2030	B53/2020	Healthy Volunteers in Hosted Research in UHL Research & Innovation

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